ASTM F3352-19

Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

SCOPE
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.  
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.  
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Historical
• Publication Date: 31-May-2019
• ICS: 11.020.99 - Other standards related to health care in general
• ICS: 11.100.99 - Other standards related to laboratory medicine
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F3352 −19
Standard Specification for
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Isolation Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F3352; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Healthcarepersonalprotectiveequipment,includingisolationgowns,iswornbyhealthcareworkers
to protect the patient, the healthcare worker, and visitors from the transfer of microorganisms, blood
and other body fluids, and other contaminants.
Healthcare workers and patients can be exposed to body fluids and other potentially infectious
materials capable of transmitting diseases. These diseases, which may be caused by a variety of
microorganisms, can pose significant risks to life and health. This is especially true of bloodborne
pathogens, such as Hepatitis (Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)) and Human
Immunodeficiency Virus (HIV), as well as other healthcare-associated infections. Since engineering
controlscannoteliminateallpossibleexposures,attentionisplacedonreducingthepotentialfordirect
skin contact with microorganisms, blood or other body fluids, and other potentially infectious
materials through the use of protective clothing.
The ASTM F23.40 Biological Subcommittee work group surveyed infection preventionists to
determine use/wear issues, familiarity with isolation gown performance standards, and to identify
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compliance perceptions and problems. Results of this survey clearly indicated issues with the
physical performance of the isolation gowns used in the healthcare settings. Development of this
standard, which includes performance and design criteria for isolation gowns, is intended to assist end
users in correct gown selection. The minimum criteria in this specification were established based on
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thefindingsofastudyincollaborationwithNationalInstituteforOccupationalSafetyandHealth and
committee discussions.
This specification addresses the performance of isolation gowns designed to protect the healthcare
worker, the patient, and visitors from exposure to blood, body fluids, and other potentially infectious
materials during patient care or patient procedures.
This specification establishes uniform testing and reporting requirements for isolation gown
manufacturers in order to provide information to end users that can be used in making informed
decisions in the evaluation, selection, and purchase of isolation gowns according to the anticipated
exposures.
1. Scope standard and transmission-based precautions.The intended use
of this specification is to ensure the performance properties of
1.1 This specification establishes minimum requirements
isolation gowns for the protection of the wearer. Four levels of
for the performance and labeling of isolation gowns intended
barrier properties for isolation gowns are specified in ANSI/
for use by healthcare workers to provide protection for
AAMI PB 70, and are included in this specification for
reference purposes.
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This specification is under the jurisdiction of ASTM Committee F23 on
Personal Protective Clothing and Equipment and is the direct responsibility of
1.2 There are other types of gowns that are used in health-
Subcommittee F23.40 on Biological.
care settings, including: cover gowns, procedure gowns, com-
CurrenteditionapprovedJune1,2019.PublishedJuly2019.Originallyapproved
fort gowns, precaution gowns, and open-back gowns. All
in 2019. DOI: 10.1520/F3352-19.
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Cloud, R., Favret, U. B., Cunningham,T., Daley, J., Harris, L. G., Kilinc-Balci,
gowns not meeting the definition of isolation gown in 3.1.7 as
F.S.,andLewis,J.A.,“IsolationGownUse,PerformanceandPotentialCompliance
defined byANSI/AAMI PB70 are excluded from this standard.
Issues Identified by Infection Control Professionals,” American Journal of Infection
Control, Vol 40, No. 5, 2012, pp. e74–e75.
1.3 This specification does not address protective clothing
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Kilinc-Balci, F. S., Nwoko, J., and Hillam, T., “Evaluation of the Performance
used for surgical applications, such as surgical gowns or
of Isolation Gowns,” American Journal of Infection Control,Vol 43, No. 6, 2015, p.
S44. decontaminationgowns;protectiveclothingforthehands,such
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F3352−19
assurgicalgloves,patientexaminationgloves,orothermedical F1868 Test Method for Thermal and Evaporative Resistance
gloves;protectiveclothingforthehead,suchasgogglesorface of Clothing Materials Using a Sweating Hot Plate
shields, surgical caps or hoods, s
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